Simecrin 120 mg 24 chewable tablets

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Symptomatic treatment of gastrointestinal meteorism and aerophagia in adults.

ACTIVE INGREDIENTS

Simecrin 40 mg chewable tablets One tablet contains: Active ingredient: simethicone mg 40 Excipient with known effects: 158.8 mg of lactose. Simecrin 80 mg chewable tablets One tablet contains Active ingredient: simethicone mg 80 Excipient with known effects: 317.6 mg of lactose. Simecrin 120 mg chewable tablets One tablet contains: Active ingredient: simethicone 120 mg Excipient with known effects: 476.4 mg of lactose. Simecrin 80 mg/ml oral emulsion 1 ml of emulsion contains: Active ingredient: simethicone 80 mg Excipients with known effect: methyl parahydroxy benzoate 0.9 mg, propyl parahydroxy benzoate 0.1 mg and sodium 2.71 mg. For the complete list of excipients see paragraph 6.1

EXCIPIENTS

Chewable tablets Mannitol (E421), hydrated colloidal silica, pregelatinized starch, lactose monohydrate, polyvinylpyrrolidone K30, crospovidone, talc, magnesium stearate, mint flavour. Oral emulsion: Citric acid monohydrate, Sodium citrate, Carbomers, Sodium saccharin, Hypromellose, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Tuttifrutti flavour, Purified water.

CONTRAINDICATIONS AND SIDE EFFECTS

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1. Generally contraindicated during pregnancy (see section 4.6).

DOSAGE

Adults: Simecrin 40 mg Chewable Tablets: 4 tablets per day (two at the end of each main meal). Simecrin 80 mg Chewable Tablets: 2 tablets per day (one at the end of each main meal). Simecrin 120 mg Chewable Tablets: 2 tablets per day (one at the end of each main meal). The tablets must be chewed. Simecrin 80 mg/ml oral emulsion: 1-1.5 ml (at the end of each main meal). The prescribed quantity of oral emulsion should be taken with the measuring syringe and dispersed in a glass of water.

CONSERVATION

Chewable tablets: store the medicine in the original packaging to protect the product from light and humidity.

WARNINGS

Do not exceed the recommended doses. After a short period of treatment without appreciable results, consult your doctor. Important information about some excipients The chewable tablets contain lactose: patients suffering from rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. The oral emulsion contains para-hydroxybenzoates which may cause allergic reactions (even delayed). The oral emulsion contains less than 1 mmol (23 mg) sodium per ml, i.e. essentially 'sodium-free'.

INTERACTIONS

There are no known, nor have been reported, interactions with other drugs.

SIDE EFFECTS

No side effects due to Simecrin have been highlighted. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

No overdose phenomena have been reported with the use of Simecrin.

PREGNANCY AND BREASTFEEDING

Pregnancy There are no adequate data on the use of Simecrin in pregnant women, therefore it should not be used during pregnancy unless there is a real need and after a risk/benefit assessment by the doctor. Breastfeeding It is not known whether simethicone is excreted in breast milk. The excretion of simethicone in breast milk has not been studied in animals. The decision whether to continue/discontinue breastfeeding or to continue/discontinue simethicone therapy should be made taking into account the benefit of breastfeeding for the infant and of simethicone therapy for the woman.

EFFECTS ON DRIVING ABILITY

No effects on the ability to drive or use machines are reported.